T2Bacteria Panel
FDA 510(k) clearance K172708 · decided 2018-05-24
Clearance details
- K-number
- K172708
- Device name
- T2Bacteria Panel
- Applicant
- T2biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-08
- Decision date
- 2018-05-24
- Days to decision
- 258 days
- Clearance type
- Traditional
- Product code
- QBX
- Device class
- 2
- Regulation number
- 866.3960
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Lexington, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| T2Bacteria® Panel (K233184) | T2biosystems, Inc. | 2024-02-08 |
Recalls involving this device
No recalls on record reference this clearance.